האיחוד האירופי - גרמנית - EMA (European Medicines Agency)

leo pharma a/s - tacrolimus - dermatitis, atopisch - andere dermatologische präparate - flare treatmentadults and adolescents (16 years of age and above)treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. children (two years of age and above)treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids. maintenance treatmentmaintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i. vorkommenden vier oder mehr mal pro jahr), die bereits eine erste antwort zu einem maximum von sechs wochen behandlung mit zweimal täglich tacrolimus-salbe (läsionen gelöscht, fast ausgeglichen oder leicht betroffen).

גרמניה - גרמנית - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

accord healthcare b.v. (8182087) - cytarabin - injektions-/infusionslösung - teil 1 - injektions-/infusionslösung; cytarabin (04666) 100 milligramm

האיחוד האירופי - גרמנית - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - mittel gegen dermatitis, ausgenommen corticosteroide - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

האיחוד האירופי - גרמנית - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - antineoplastische mittel - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

האיחוד האירופי - גרמנית - EMA (European Medicines Agency)

astrazeneca ab - tezepelumab - asthma - medikamente für obstruktive atemwegserkrankungen, - tezspire is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

האיחוד האירופי - גרמנית - EMA (European Medicines Agency)

nordic group b.v. - methotrexat - arthritis, psoriatic; psoriasis; arthritis, juvenile rheumatoid; arthritis, rheumatoid - antineoplastische mittel - nordimet is indicated for the treatment of:active rheumatoid arthritis in adult patients,polyarthritic forms of severe, active juvenile idiopathic arthritis (jia), when the response to nonsteroidal anti-inflammatory drugs (nsaids) has been inadequate,moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and severe psoriatic arthritis in adult patients, induction of remission in moderate steroid-dependent crohn's disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate.

האיחוד האירופי - גרמנית - EMA (European Medicines Agency)

pfizer europe ma eeig - pemetrexed disodium, pemetrexed disodium hemipentahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastische mittel - malignant pleural mesotheliomapemetrexed pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancerpemetrexed pfizer in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed pfizer is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. pemetrexed pfizer is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

האיחוד האירופי - גרמנית - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - quizartinib dihydrochloride - leukämie, myeloid - antineoplastic agents, protein kinase inhibitors - vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by vanflyta single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (aml) that is flt3-itd positive.

האיחוד האירופי - גרמנית - EMA (European Medicines Agency)

takeda pharma a/s - fentanyl-citrat - pain; cancer - analgetika - instanyl ist indiziert für die behandlung von durchbruchschmerzen bei erwachsenen, die bereits eine opioid-therapie zur behandlung von chronischen tumorschmerzen erhalten. durchbruchschmerz ist eine vorübergehende verschlimmerung des schmerzes, die vor dem hintergrund eines ansonsten kontrollierten anhaltenden schmerzes auftritt.  patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

האיחוד האירופי - גרמנית - EMA (European Medicines Agency)

merck europe b.v. - avelumab - neuroendokrine tumoren - andere antineoplastische wirkstoffe, monoklonale antikörper - bavencio ist indiziert als monotherapie für die behandlung von erwachsenen patienten mit metastatic merkel cell carcinoma (mcc). bavencio in kombination mit axitinib ist angezeigt für die first-line-behandlung von erwachsenen patienten mit fortgeschrittenem nierenzellkarzinom (rcc). bavencio is indicated as monotherapy for the first‑line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc) who are progression-free following platinum‑based chemotherapy.